Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06565494
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-26
Brief Title:
MDMA-Assisted Therapy for Pathological Narcissism
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Pilot Study of Midomafetamine MDMA-Assisted Therapy for the Treatment of Pathological Narcissism
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This open-label proof-of-concept pilot study will assess the efficacy and safety of midomafetamine MDMA - assisted therapy AT for participants diagnosed with pathological narcissism As all participants will be allocated to a single group assignment there will be no blinding randomization or comparator treatment Participants will have a screening visit a preparation period of 3 visits a treatment period receiving MDMA-AT at 3 monthly visits a 6 month follow up period coming in at one week one month three months and six months after last treatment visit
Detailed Description:
This open-label proof-of-concept pilot study will assess the efficacy and safety of midomafetamine- assisted therapy MDMA-AT for participants diagnosed with pathological narcissism As all participants will be allocated to a single group assignment there will be no blinding randomization or comparator treatment
Up to 12 participants will be enrolled Each participant will have 2 informants one family member and one psychotherapist
The visit schedule for each participant will be comprised of the following
Screening Period phone screen visit screen informed consent eligibility assessment and enrollment invitation to eligible participants
Preparation Period medication tapering three Preparation Sessions Baseline assessments Enrollment Confirmation
Treatment Period three monthly Experimental Sessions and nine associated Integration Sessions over 12 weeks
Follow-up Period and Study Termination four Follow-up Visits at one week one month three months and six months after the final Integration Session to collect clinical outcome measures Study Termination will happen at the last Follow-up Visit
The treatment MDMA-AT consists 3 Preparation sessions followed by 3 Experimental sessions at 4-week intervals after each Experimental session 3 weekly Integration sessions will be conducted For the first Experimental Session the dose of MDMA is 80 mg for the second and third Experimental Sessions the dose of MDMA is 120 mg For all three Experimental sessions a supplemental dose of 50 of the initial dose will be available The Preparation Experimental and Integration Sessions will involve psychotherapy developed specifically for this trial and population
Up to 12 participants will be enrolled Each participant will have 2 informants one family member and one psychotherapist
The visit schedule for each participant will be comprised of the following
Screening Period phone screen visit screen informed consent eligibility assessment and enrollment invitation to eligible participants
Preparation Period medication tapering three Preparation Sessions Baseline assessments Enrollment Confirmation
Treatment Period three monthly Experimental Sessions and nine associated Integration Sessions over 12 weeks
Follow-up Period and Study Termination four Follow-up Visits at one week one month three months and six months after the final Integration Session to collect clinical outcome measures Study Termination will happen at the last Follow-up Visit
The treatment MDMA-AT consists 3 Preparation sessions followed by 3 Experimental sessions at 4-week intervals after each Experimental session 3 weekly Integration sessions will be conducted For the first Experimental Session the dose of MDMA is 80 mg for the second and third Experimental Sessions the dose of MDMA is 120 mg For all three Experimental sessions a supplemental dose of 50 of the initial dose will be available The Preparation Experimental and Integration Sessions will involve psychotherapy developed specifically for this trial and population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None